K-number	K202883
Device name	Sterile bone screw (PEEK ACL screw)
Applicant	Osteonic Co., Ltd.
Product code	MBI
Device class	Class II
Decision date	Nov 25, 2020
Decision	Substantially Equivalent
Regulation	888.3040

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Source

View the full FDA submission: accessdata.fda.gov

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Sterile bone screw (PEEK ACL screw)

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